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FDA 510(k)

Chaorum Implant System

K-Number: K160536 · 2017-01-05

ApplicantMedimecca Co., Ltd.
Decision Date2017-01-05
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Chaorum Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Medimecca Co., Ltd.. It received FDA 510(k) clearance on 2017-01-05 under 510(k) number K160536. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Chaorum Implant System?

Chaorum Implant System is a medical device that received FDA 510(k) clearance on 2017-01-05. The listed applicant is Medimecca Co., Ltd.. The 510(k) number is K160536.

When did Chaorum Implant System receive FDA 510(k) clearance?

Chaorum Implant System received FDA 510(k) clearance on 2017-01-05, under 510(k) number K160536.

Who is the listed applicant for Chaorum Implant System?

The FDA 510(k) record lists Medimecca Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Chaorum Implant System?

The FDA product code for Chaorum Implant System is DZE.

Other records listing Medimecca Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DZE)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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